[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557510":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":10,"responsibleParty":32,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":10,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"migrants",null,"All migrants, documents or undocumented migrants, and low-income refugees belonging to the infectious disease centers of the university centers participating in the project will be enrolled.\n\nAll HBsAg-positive subjects will be linked to the tertiary centers. The cultural mediator will accompany the migrants testing positive to the screening to stage the liver disease and to start the therapeutic management of subjects with HBV infection and HBV HDV co-infection according to international guidelines.\n\nIn the Retrospective phase of the project about 2000 stored samples of migrant enrolled in a previous study will be re-tested for HBsAG, HCV Ab and HIV ab. In the same blood sample testing positive for HBsAg, anti-HDV will be tested; in cases of anti-HDV positivity the same serum sample will be collected to test HDV RNA.",[13],"Diagnostic Test: anti-HDV positive with the reflex testing methodology",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","anti-HDV positive with the reflex testing methodology","Rate of screening for HBsAg in all migrants attending to one of the center participating to the project rate of screening for anti-Delta in all HBsAg patients identified rate of anti-Delta-positivity in HBsAg-positive subjects rate of linkage-to-care at one of the infectious disease center participating to the project rate of HDV-RNA testing in all anti-Delta positive subjects rate of treatment for HDV in all HDV-RNA-positive subjects Rate of screening for HIV Ab in all migrants attending to one of the center participating to the project Rate of screening for HCV Ab in all migrants attending to one of the center participating to the project.",[9],[21],{"name":22,"affiliation":5,"role":23},"Nicola Coppola, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+390815666223","nicola.coppola@unicampania.it",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"Laura Occhiello, SC","laura.occhiello@unicampania.it",{"type":23,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Nicola Coppola","Chief of Infectoius Diseases Unit",[36],{"name":37,"class":38},"Gilead Sciences","INDUSTRY","100557510","migrant-reflex-test-hdv-migred-project-100557510",false,"NCT06539052","MIGrant Reflex Test HDV (MIGRED) Project","A Model to Improve the Screening and Linkage to Care of HDV Infection in Migrant Living in Southern Italy Taking Advantage of HDV Reflex Testing: MIGrant Reflex Test HDV (MIGRED) Project","Inclusion Criteria:\n\n* All migrants, documents or undocumented migrants, and low-income refugees belonging to the infectious disease centers of the university centers participating in the project will be enrolled. aged \\> 18 years subjects who have given informed consent to carry out blood sampling and for the collection of epidemiological data\n\nExclusion Criteria:\n\n* all migrants \\\u003C 18 years of age who have not given informed consent for the collection of the blood sample and\u002For epidemiological data.","ALL","18 Years",{"count":49,"type":50},7500,"ESTIMATED","2 Months","OBSERVATIONAL","Our research team has executed a robust strategy to improve viral hepatitis detection and linkage to care in migrants, contributing to the improvement of knowledge on the clinical and virological future of viral hepatitis in this population difficult to reach and manage. Our hypothesis is that the extension of our model to three other large university clinical centers operating in southern Italy and the use of HDV reflex testing for HBsAg-positive subjects will allow the implementation of knowledge on prevalence of HDV in migrants living in southern Italy and coming from HDV endemic areas. Precisely, the investigators will involve the Department of Infectious Diseases of the University of Bari, that of the University of Catanzaro and that of the University of Palermo with expertise in the management of infectious diseases in the migratory context and with whom the investigators have previously collaborated in other areas.\n\nIt is expected to enroll at least 7500 patients. The project will last 18 months.\n\nDiagnosis and treatment of HDV infection in migrants will reduce the circulation of HDV in low endemic regions such as our region. Follow-up of HDV-infected individuals and reducing the rate of new infections among migrants will reduce the number of people who will experience complications related to HDV infection, such as decompensated liver cirrhosis and carcinoma hepatocellular. All this will determine benefits for the Italian public health system.",[55],"Hepatitis D Virus Infection","NOT_YET_RECRUITING","2024-12-17",{"date":59,"type":60},"2024-12-18","ACTUAL",{"date":62,"type":50},"2024-12-20",{"date":64,"type":50},"2026-12-20",{"name":5,"class":6}]